Article (Scientific journals)
Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.
Galmiche, Jean-Paul; Hatlebakk, Jan; Attwood, Stephen et al.
2011In JAMA: Journal of the American Medical Association, 305 (19), p. 1969-77
Peer Reviewed verified by ORBi
 

Files


Full Text
2011-Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD...-JAMA-PostPE.pdf
Publisher postprint (431.52 kB)
Request a copy

All documents in ORBi are protected by a user license.

Send to



Details



Keywords :
Adult; Anti-Ulcer Agents/administration & dosage/adverse effects; Chronic Disease; Digestive System Surgical Procedures/adverse effects/methods; Female; Gastroesophageal Reflux/drug therapy/surgery; Humans; Laparoscopy/adverse effects/methods; Male; Middle Aged; Omeprazole/administration & dosage/adverse effects; Remission Induction; Severity of Illness Index; Treatment Outcome
Abstract :
[en] CONTEXT: Gastroesophageal reflux disease (GERD) is a chronic, relapsing disease with symptoms that have negative effects on daily life. Two treatment options are long-term medication or surgery. OBJECTIVE: To evaluate optimized esomeprazole therapy vs standardized laparoscopic antireflux surgery (LARS) in patients with GERD. DESIGN, SETTING, AND PARTICIPANTS: The LOTUS trial, a 5-year exploratory randomized, open, parallel-group trial conducted in academic hospitals in 11 European countries between October 2001 and April 2009 among 554 patients with well-established chronic GERD who initially responded to acid suppression. A total of 372 patients (esomeprazole, n = 192; LARS, n = 180) completed 5-year follow-up. Interventions Two hundred sixty-six patients were randomly assigned to receive esomeprazole, 20 to 40 mg/d, allowing for dose adjustments; 288 were randomly assigned to undergo LARS, of whom 248 actually underwent the operation. MAIN OUTCOME MEASURE: Time to treatment failure (for LARS, defined as need for acid suppressive therapy; for esomeprazole, inadequate symptom control after dose adjustment), expressed as estimated remission rates and analyzed using the Kaplan-Meier method. RESULTS: Estimated remission rates at 5 years were 92% (95% confidence interval [CI], 89%-96%) in the esomeprazole group and 85% (95% CI, 81%-90%) in the LARS group (log-rank P = .048). The difference between groups was no longer statistically significant following best-case scenario modeling of the effects of study dropout. The prevalence and severity of symptoms at 5 years in the esomeprazole and LARS groups, respectively, were 16% and 8% for heartburn (P = .14), 13% and 2% for acid regurgitation (P < .001), 5% and 11% for dysphagia (P < .001), 28% and 40% for bloating (P < .001), and 40% and 57% for flatulence (P < .001). Mortality during the study was low (4 deaths in the esomeprazole group and 1 death in the LARS group) and not attributed to treatment, and the percentages of patients reporting serious adverse events were similar in the esomeprazole group (24.1%) and in the LARS group (28.6%). CONCLUSION: This multicenter clinical trial demonstrated that with contemporary antireflux therapy for GERD, either by drug-induced acid suppression with esomeprazole or by LARS, most patients achieve and remain in remission at 5 years. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00251927.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Galmiche, Jean-Paul
Hatlebakk, Jan
Attwood, Stephen
Ell, Christian
Fiocca, Roberto
Eklund, Stefan
Langstrom, Goran
Lind, Tore
Lundell, Lars
Louis, Edouard  ;  Université de Liège - ULiège > Département des sciences cliniques > Hépato-gastroentérologie
Language :
English
Title :
Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial.
Publication date :
2011
Journal title :
JAMA: Journal of the American Medical Association
ISSN :
0098-7484
eISSN :
1538-3598
Publisher :
American Medical Association, Chicago, United States - Illinois
Volume :
305
Issue :
19
Pages :
1969-77
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 16 January 2012

Statistics


Number of views
71 (1 by ULiège)
Number of downloads
0 (0 by ULiège)

Scopus citations®
 
387
Scopus citations®
without self-citations
362
OpenCitations
 
305

Bibliography


Similar publications



Contact ORBi